BACKGROUND: Against the backdrop of the debate on extending working life, it is important to identify vulnerable occupational groups by analysing inequalities in healthy life years. The aim of the study is to analyse partial life expectancy (age 30-65) [1] free of musculoskeletal diseases (MSD) and [2] free of cardiovascular diseases (CVD) in occupational groups with different levels of physical and psychosocial exposures.
METHODS: The study is based on German health insurance claims data from 2015 to 2018. The study population comprises all employed insured persons aged 18 to 65 years (N = 1,528,523). Occupational exposures were assessed using a Job Exposure Matrix. Life years free of MSD / CVD and life years with MSD /CVD during working age were estimated using multistate life tables.
RESULTS: We found inequalities in MSD-free and CVD-free life years, with less disease-free years among men and women having jobs with high levels of physical and psychosocial exposures. Men with low physical exposures had 2.4 more MSD-free and 0.7 more CVD-free years than men with high physical exposures. Women with low psychosocial exposures had 1.7 MSD-free and 1.0 CVD-free years more than women with high psychosocial exposures.
CONCLUSIONS: Employees in occupations with high physical and psychosocial demands constitute vulnerable groups for reduced life expectancy free of MSD and CVD. Given the inequalities and high numbers of disease-affected life years during working age, the prevention potential of occupational health care and workplace health promotion should be used more extensively.

Onychomycosis, a fungal nail infection, is a common dermatological condition in Japan, with a prevalence of approximately 5%-10%. Despite the introduction of new antifungal medications and updated treatment guidelines published in 2019, data on real-world prescription trends and the associated medical costs are limited. This study aimed to investigate the prescription patterns and medical costs of topical and oral antifungal medications for onychomycosis in Japan from fiscal years 2014 to 2021 using the National Database of Health Insurance Claims and Specific Health Checkups of Japan Open Data. We analyzed the annual prescription volumes and medical costs of four antifungal medications: efinaconazole, luliconazole, fosravuconazole, and terbinafine. The prescription volume of efinaconazole, a topical medication launched in 2014, rapidly increased and dominated the market share. Fosravuconazole, an oral medication introduced in 2018, showed an increasing trend, coinciding with a decline in efinaconazole prescriptions. Terbinafine, a well-established oral medication, experienced a substantial decrease in prescription volume. The sex- and age-adjusted prescription volume per 100 000 population was higher among older adults, particularly for efinaconazole. The total medical costs for onychomycosis treatment more than doubled in fiscal year 2015 compared with that for 2014, mainly driven by efinaconazole prescriptions, and exceeded 30 billion Japanese yen in fiscal years 2019-2021. The costs slightly decreased in fiscal years 2020 and 2021, possibly due to the introduction of fosravuconazole. The predominance of topical prescriptions, especially in older adults, raises concerns regarding adherence to the Japanese guidelines that recommend oral antifungals as the first-line treatment for onychomycosis. The substantial increase in medical costs also highlights the economic burden of onychomycosis and the need for cost-effective treatment strategies. This study provides valuable insights into the real-world prescription trends and medical costs of onychomycosis treatment in Japan, suggesting an opportunity to assess potential gaps between guideline recommendations and clinical practice.

OBJECTIVE: There is limited data on the incidence, prevalence, and treatments for myelofibrosis (MF) in Germany. This retrospective study examined claims data from 3.3 million insured individuals, spanning from 2010 to 2021.
METHODS: Four sensitivity scenarios were explored to identify cases of MF. Point prevalence and cumulative incidence of MF were determined as of December 31, 2021, and within 2021, respectively. A cross-sectional analysis used the main scenario definition of MF to identify cases and evaluate the period prevalence of patients receiving treatment for symptoms and/or splenomegaly, including first-line (1L) Janus kinase inhibitor (JAKi), second-line, or further (2L+) MF-related treatment therapies during 2021. The prevalence of anemia treatment was also reported.
RESULTS: The estimated standardized point prevalence of MF on December 31, 2021, was 9.9-12.4 cases per 100 000 persons, and cumulative incidence in 2021 was 1.2-1.8 cases per 100 000 persons. Standardized period prevalence in 2021 for MF patients receiving 1L JAKi and/or 2L+ MF-related treatment was 4.0 cases per 100 000. Among these patients, 47.1%-53.7% required treatment for anemia, resulting in a period prevalence of 1.9-2.2 cases per 100 000 individuals.
CONCLUSIONS: The data reveal gaps in MF treatments and the need to improve patient quality of life.

BACKGROUND: The randomized, dose-optimization, open-label ReDOS study in US patients with metastatic colorectal cancer (CRC) showed that, compared with a standard dosing approach, initiating regorafenib at 80 mg/day and escalating to 160 mg/day depending on tolerability increased the proportion of patients reaching their third treatment cycle and reduced the incidence of adverse events without compromising efficacy. Subsequently, the ReDOS dose-escalation strategy was included as an alternative regorafenib dosing option in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines. A retrospective analysis was conducted using a US claims database to assess whether inclusion of this dose-escalation strategy in NCCN Guidelines has influenced the use of flexible dosing in routine US clinical practice, and to describe clinical outcomes pre- and post-inclusion in NCCN Guidelines.
METHODS: Patients with CRC in the Optum\'s de-identified Clinformatics® Data Mart database initiating regorafenib for the first time between January 2016 and June 2020 were stratified based on whether they initiated regorafenib pre- or post-inclusion of ReDOS in NCCN Guidelines, and in two groups: flexible dosing (< 160 mg/day; < 84 tablets in the first treatment cycle) and standard dosing (160 mg/day; ≥ 84 tablets in the first treatment cycle). The primary endpoints were the proportion of patients who initiated their third treatment cycle and the mean number of treatment cycles per group.
RESULTS: 703 patients initiated regorafenib during the study period, of whom 310 (44%) initiated before and 393 (56%) initiated after inclusion of ReDOS in NCCN Guidelines. After inclusion in the guidelines, the proportion of patients who received flexible dosing increased from 21% (n = 66/310) to 45% (n = 178/393), the proportion who received standard dosing decreased from 79% (n = 244/310) to 55% (n = 215/393), the proportion who initiated their third treatment cycle increased from 36% (n = 113/310) to 46% (n = 179/393), and the mean (standard deviation) number of treatment cycles increased from 2.6 (2.9) to 3.2 (3.1).
CONCLUSIONS: Following inclusion of ReDOS in NCCN Guidelines, real-world data suggest that US clinicians have markedly increased use of flexible dosing in clinical practice, potentially maximizing clinical benefits and safety outcomes for patients with metastatic CRC receiving regorafenib.

UNASSIGNED: Biologic agents have demonstrated efficacy in treating ulcerative colitis (UC); however, treatment failure to tumor necrosis factor inhibitors (TNFi) is common in the real world. Data on preferential sequencing in clinical practice after failure remain limited.
UNASSIGNED: This study aimed to evaluate real-world outcomes of patients cycling to TNFis or switching to non-TNFi biologics following first-line failure with TNFis.
UNASSIGNED: Retrospective cohort study in Germany.
UNASSIGNED: Adult patients with UC were identified using administrative claims data from 1 May 2014 to 30 June 2022 provided by a statutory sickness fund. Patients newly initiating first-line therapy with TNFis and then switching to another agent were identified. Patients were defined as within-class switched (WCS), if they cycled to another TNFi, or outside-class switchers (OCS), if they switched to a non-TNFi biologic [ustekinumab (UST) or vedolizumab (VDZ)] and followed from index (switch date) to death, insurance end, or study end on 30 June 2022. Inverse probability of treatment weighting (IPTW) was performed to adjust for differences in baseline characteristics between groups, and weighted Cox regression models were used to compare primary (time to discontinuation and second treatment switch) and secondary outcomes (corticosteroid-free drug survival).
UNASSIGNED: We identified 166 patients initiating TNFis and switching to a subsequent treatment (mean age: 42.9 years, 49.4% female). Following IPTW, there were 71 and 76 patients in the WCS and OCS groups, respectively. Compared to OCS, WCS were more likely to discontinue the new therapy [hazard ratio (HR), 1.82, 95% confidence interval (CI), 1.14-2.89, p = 0.012], and switch a second time (HR, 3.46, 95% CI, 1.89-6.36, p < 0.001). Moreover, WCS showed an increased likelihood of initiating prolonged corticosteroid therapy (HR, 1.42, 95% CI, 0.77-2.59, p = 0.260); however, the results were not significant.
UNASSIGNED: Following first-line TNFi failure, this study suggests that real-world outcomes among patients with UC are less favorable when cycling to another TNFi, compared to switching to a non-TNFi such as UST or VDZ.

OBJECTIVE: Japan started the Diabetic Nephropathy Aggravation Prevention Program. Its early impact was assessed in this study.
METHODS: This study used the Kokuho Database of patients with type 2 diabetes from program-implementing and non-implementing municipalities (fiscal years [FYs] 2015-2021). Implementing municipalities facilitated clinic visits and provided education to eligible patients. Average treatment effects on the treated in FYs 2016 and 2018 were evaluated using the inverse probability of treatment weighting. Comparison included intervened vs. non-intervened patients in program-implementing municipalities (Comparison A), intervened patients in program-implementing vs. eligible patients in non-implementing municipalities (Comparison B), and eligible patients in implementing and non-implementing municipalities (Comparison C).
RESULTS: Overall, 89,611/89,685 patients from FY 2016/2018 were eligible. Among 68,125/68,170 patients in program-implementing municipalities, 1,470/1,819 were intervened. In Comparison A, the estimated effect of the program on ΔeGFR at 3 years were -0.4 (95 % confidence interval; -1.0, 0.2)/-0.4 (-0.9, 0.1) mL/min/1.73 m2 in FY 2016/2018. Comparisons B and C demonstrated similar tendency; distribution of %change in eGFR varied between municipalities.
CONCLUSIONS: Early in the program, renal function did not improve in the intervened patients or program-implementing municipalities. Diverse eGFR changes across municipalities highlighted diverse intervention outcomes, emphasizing the need of program refinement.

UNASSIGNED: This study aimed to describe the migraine burden and healthcare utilization in the context of headache frequency using nationwide claims data linked to online survey data previously collected in Japan.
UNASSIGNED: It has been shown that increase in headache frequency can impose greater impact on individuals\' daily and social functioning, but migraine burden in those with low-frequency headaches remains largely unknown in Japan.
UNASSIGNED: This post-hoc, observational study reported on 674 respondents who were working individuals and their family members aged 19-74 years, responded to an online questionnaire (response rate: 14.1% [21,704 responded/153,545 kencomⓇ registrants]), and were previously classified as having migraine. Disease burden in terms of Migraine-Specific Quality of Life (MSQ) and Work Productivity and Activity Impairment (WPAI) was compared across 0-3, 4-7, 8-14, and ≥ 15 monthly headache days (MHD).
UNASSIGNED: Among 674 respondents, 419 (62.2%), 148 (22.0%), 61 (9.1%), and 46 (6.8%) had 0-3, 4-7, 8-14, and ≥ 15 MHD, respectively. Of those, 55 (13.1%), 31 (20.9%), 19 (31.1%), and 20 (43.5%) respondents consulted physicians for headaches. Moderate-to-severe impairments in daily activities were reported by 298 (71.1%), 110 (74.3%), 46 (75.4%), and 38 (82.6%) respondents. The proportion of the respondents with WPAI >0% generally increased with increasing headache frequency (presenteeism: 41.7 and 67.5% in respondents with 0-3 and ≥ 15 MHD, respectively; overall work impairment: 44.8 and 72.5%, respectively; and activity impairment: 44.9 and 73.9%, respectively), except for absenteeism (12.4 and 22.5%, respectively). The mean MSQ score declined with increasing MHD (Role function-restrictive: 75.1 and 59.5 in those with 0-3 and ≥ 15 MHD, respectively; Role function-preventive: 85.8 and 75.0, respectively; and Emotional function: 81.9 and 63.6, respectively).
UNASSIGNED: Based on the Japanese nationwide claims data, quality of life and work productivity decreased with increasing numbers of headache days. Substantial disease burden paired with low levels of healthcare utilization highlights the need for medical or non-medical intervention.

BACKGROUND: This study aimed to validate self-reported medical conditions in the Taiwan Biobank (TWBB), in which participants were inquired about 30 disease conditions, by comparing them with claims records from Taiwan\'s National Health Insurance (NHI) claims database.
METHODS: We identified 30 clinical diagnoses using ICD-CM codes from ambulatory and hospital claims within the NHI claims database, matching diseases included in the TWBB. The concordance between self-reports and claims records was evaluated using tetrachoric correlation to assess the correlation between binary variables.
RESULTS: A total of 131,834 participants aged 30-70 years with data from the TWBB and NHI records were included. Concordance analysis revealed tetrachoric correlations ranged from 0.420 (chronic obstructive pulmonary disease) to 0.970 (multiple sclerosis). However, several disorders exhibited lower tetrachoric correlations. The concordance was higher among those with higher education attainment, and lower among married individuals.
CONCLUSIONS: The concordance between self-reports in the TWBB and NHI claims records varied across clinical diagnoses, showing inconsistencies depending on participant characteristics. These findings underscore the need for further investigation, especially when these variables are crucial to research objectives. Integrating complementary databases such as clinical diagnoses, prescription records, and medical procedures can enhance accuracy through customized algorithms based on disease categories and participant characteristics and optimize sensitivity or positive predictive values to align with specific research objectives.

OBJECTIVE: There is a lack of real-world data in Asian populations for brigatinib, a next-generation anaplastic lymphoma kinase (ALK) inhibitor for patients with non-small cell lung cancer (NSCLC). This study analysed real-world outcomes and dosing patterns for brigatinib in patients with crizotinib-refractory ALK+ NSCLC in South Korea.
METHODS: This retrospective, non-interventional, cohort study used South Korean Health Insurance and Review Assessment claims data for adults with ALK+ NSCLC who initiated brigatinib between 19 April 2019 and 31 March 2021 after receiving prior crizotinib. Patients\' characteristics, time to discontinuation (TTD), time to dose reduction, overall survival (OS) and treatment adherence were assessed.
RESULTS: The study included 174 patients (56.9% male; 27.0% with a history of brain metastases). Median duration of prior crizotinib was 17 (range 0.3-48) months. Median follow-up after brigatinib initiation was 18 (range 0-34) months. Overall, 88.5% of patients received full-dose brigatinib (180 mg/day) and 93.1% of patients were adherent (proportion of days covered ≥0.8). The median TTD was 24.9 months (95% CI 15.2-not reached). The probability of continuing treatment was 63.2% at 1 year and 51.5% at 2 years. The probability of continuing at full or peak dose was 79.7% at 1 year and 75.6% at 2 years. Median OS was not reached. The 2-year OS rate was 68.7%.
CONCLUSIONS: In this first nationwide retrospective study using national insurance claim data, brigatinib demonstrated real-world clinical benefit as second-line treatment after prior crizotinib in ALK+ NSCLC patients in South Korea.

Electronic health record (EHR) data are seen as an important source for Pharmacoepidemiology studies. In the US healthcare system, EHR systems often only identify fragments of patients\' health information across the care continuum, including primary care, specialist care, hospitalizations, and pharmacy dispensing. This leads to unobservable information in longitudinal evaluations of medication effects causing unmeasured confounding, misclassification, and truncated follow-up times. A remedy is to link EHR data with longitudinal claims data which record all encounters during a defined enrollment period across all care settings. We evaluate EHR and claims data sources in three aspects relevant to etiologic studies of medical products: data continuity, data granularity, and data chronology. Reflecting on the strengths and limitations of EHR and insurance claims data, it becomes obvious that they complement each other. The combination of both will improve the validity of etiologic studies and expand the range of questions that can be answered. As the research community transitions towards a future state with access to large-scale combined EHR+claims data, we outline analytic templates to improve the validity and broaden the scope of pharmacoepidemiology studies in the current environment where EHR data are available only for a subset of patients with claims data.